Jul 23 2007
Medicine regulators have been accused of dragging their feet over a cannabis drug for people with multiple sclerosis.
The Medicines and Healthcare Regulatory Agency (MHRA) met last week to discuss Sativex, a drug which is a medicinal form of cannabis.
The drug which has been shown to help people with multiple sclerosis is causing a 'kerpuffle' with regulators in the UK.
Advocates for the drug which offers relief from the painful and disabling symptoms of the condition, have accused the Medicines and Healthcare Regulatory Agency (MHRA) of dragging their feet in the matter.
The MHRA says more clinical data is needed before the drug could be approved for treating MS patients but experts argue that the delay leaves many people with MS no other option than to resort to 'street' cannabis for relief.
Professor Mike Barnes, consultant neurologist at the University of Newcastle and a trustee of the MS Trust charity, says there is "compelling" evidence that the drug Sativex has been shown in trials to help a large proportion of people with MS.
On average, half the patients who tried the drug gained some benefit and there were no concerns.
The Trust says MS is a hugely variable condition with variable responses to treatments and to deny some patients because the treatment doesn't help everyone is madness.
According to the MS trust a fifth of 160 people surveyed reported a reduced need for supportive equipment or mobility assistance and almost everyone taking part in the trial experienced an improvement in general life benefits.
The trust says Sativex meets a currently unmet medical need in patients where there is no other conservative treatment option and it should be licensed and become available on prescription.
Savitex is an oral spray developed by the drugs company GW Pharmaceuticals, but is now unlikely to gain regulatory approval in Britain until 2009 despite recently winning full regulatory approval in Canada.
The company says it has now withdrawn its application for regulatory approval in the UK and Europe pending further tests in order to satisfy the MRHA which is expected to be ready in 12 months.
GW Pharma will recruit 200 new patients for the study, in addition to the 1,200 people that are already using the treatment on a named patient basis in the UK.
GW Pharma has had a licence to grow cannabis in the UK for nine years, and despite investing significant sums it is yet to make a profit.
The company has recently signed a number of high-profile distribution deals for Savitex with major pharmaceutical groups, including Otsuka in the U.S., Bayer in the UK and Canada and Almirall in Europe.
Savitex has also been developed to treat cancer pain.
Campaigners for the licensing of cannabis-derived treatments for conditions such as MS have won some support from MPs, but medical authorities have been slow to proceed.